Clinical Research Associate

1 week ago

United Kingdom MAC Clinical Research Full time

MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and progressive CRO.
The role is open to applicants who have around 7 years of clinical research experience with a minimum of 3 years as a CRA and a minimum of 2 years with independent site monitoring experience within a CRO.

This is a remote working position with travel to clinical sites for independent, study monitoring as required.

A Bachelor's degree or equivalent in a health care or other scientific discipline
A minimum of 2 years’ independent, on-site monitoring experience within clinical research either in a CRO or Sponsor company.
Excellent computer skills including use of Microsoft Office.
Excellent oral and written communicative skills, with English fluency.
Able to proactively identify risks and issues.
Knowledge of drug development process, surrounding regulatory framework and the overall clinical trial process.
Good working knowledge of the relationship between the CRO industry and pharmaceutical companies.

Performs the Project CRA role independently with appropriate escalations as needed:

Facilitates effective communications as primary contact point for investigator sites, sponsor, and MAC project team through written, oral and/or electronic contact reports.
Verify the study Investigators and site personnel are conducting the study in compliance with protocol, ICH-GCP and applicable regulatory requirements.
Conduct Pre-study or site selection (PSSV), site initiation (SIV), remote monitoring (R-IMV), risk-based monitoring (rb-IMV), close out visits (COV) according to the agreed scope of work.
Document and record monitoring activities and observations in CTMS/agreed reporting system within required timelines. Escalate observed deficiencies and issues to the Lead CRA and project team expeditiously. Develop high levels of familiarity and compliance with study specific Monitoring Plan, Project Plan and Risk Assessment, raising issues as needed.
Monitor and report on clinical study progress, working with Data Management to ensure steady flow of data and data queries as per project timelines.
Confirm reported data is correct, accurate, complete, and verifiable against source documentation as per the project Monitoring Plan. Raise data queries in the production of clean data and follow up to conclusion.
Identify and communicate potential project risks and issues.
Provide site training, acting as site process specialist, ensuring the study is conducted as per protocol, ICH GCP, applicable regulations, and SOPs to guarantee participants rights, well-being, and data reliability.
Prepare for interim or data base lock.
Review study documentation for compliance and to ensure identification and reporting of safety issues, when applicable, from research site staff to the LCRA, project team, sponsor, and the IRB/IEC.
essential documents relating to the clinical study which will enable quality and conduct to be evaluated as per ICH GCP and EudraLex, query resolution, and other data collection tools);
Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.

PLANNING AND ORGANISATION
Identify quality problems and recommend solutions.
Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
~ Health Insurance
~ Free onsite parking
~25 days annual leave (increasing in increments to 30 days after 6 years' service)
~ Your birthday off work


MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential.

  • Clinical Research Associate II

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and...

  • Clinical Research Associate II

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and...

  • Clinical Research Associate II

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and...

  • Clinical Research Associate II

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and...

  • Clinical Research Associate II

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and...

  • Senior Clinical Research Associate

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO. This is a...

  • Senior Clinical Research Associate

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO. This is a...

  • Senior Clinical Research Associate

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO. This is a...

  • Senior Clinical Research Associate

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO. This is a...

  • Senior Clinical Research Associate

    1 week ago

    United Kingdom MAC Clinical Research Full time

    MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO. This is a...

  • Clinical Research Associate

    1 month ago

    United Kingdom Hyper Recruitment Solutions Ltd Full time

    Join a pioneering team in the healthcare sector as a Contract Clinical Research Associate, operating remotely within the UK. As a Clinical Research Associate, you will play a pivotal role in advancing medical research from the comfort of your own home. Your duties as the Clinical Research Associate will be varied however the key duties and responsibilities...

  • Senior Clinical Research Associate

    1 month ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent...

  • Senior Clinical Research Associate

    1 month ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent...

  • Senior Clinical Research Associate

    3 weeks ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent...

  • Senior Clinical Research Associate

    3 weeks ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent...

  • Clinical Research Associate

    2 months ago

    United Kingdom BioTalent Full time

    Title: Clinical Research Associate Location: Hybrid- London Hourly Rate: Competitive Contract Type: 6 months Background CRA being appointed to secure sample forecast, assist with monitoring on the study and data cleaning as well as support with due diligence monitoring on the first in human programme (FiH). Project Overview and Objectives Support...

  • Senior Clinical Research Associate

    1 month ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team.Requirements:Bachelor’s degree or equivalent experience3 years’ experience as a Clinical Research Associate Background working within a CROOphthalmology experience strongly preferredKey Features:Full-time, permanent positionHome-based...

  • Senior Clinical Research Associate

    3 weeks ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent position...

  • Senior Clinical Research Associate

    1 month ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team. Requirements: Bachelor’s degree or equivalent experience 3 years’ experience as a Clinical Research Associate Background working within a CRO Ophthalmology experience strongly preferred Key Features: Full-time, permanent position...

  • Senior Clinical Research Associate

    1 month ago

    United Kingdom Life Science People Full time

    Life Science People are looking for a Senior Clinical Research Associate for one of our key clients to join their UK team.Requirements:Bachelor’s degree or equivalent experience3 years’ experience as a Clinical Research Associate Background working within a CROOphthalmology experience strongly preferredKey Features:Full-time, permanent positionHome-based...